Overview
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Refractory Hodgkin's Disease or Non-Hodgkin's Lymphoma
Status:
Completed
Completed
Trial end date:
1991-07-01
1991-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy to kill more cancer cells. PURPOSE: This phase II trial is studying giving high-dose chemotherapy followed by bone marrow or peripheral stem cell transplantation to see how well it works in treating patients with refractory Hodgkin's disease or non-Hodgkin's lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Carmustine
Cisplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Lenograstim
Sargramostim
Criteria
DISEASE CHARACTERISTICS: Diagnosis of resistant Hodgkin's disease Eligible subtypes:Lymphocytic predominance Nodular sclerosing Mixed cellularity Lymphocyte depleted Not
otherwise specified Must meet 1 of the following conditions: Disease progression after at
least 1 course of prior therapy on each of 2 regimens comprising combination chemotherapy
or radiotherapy Less than a partial remission (PR) after at least 2 courses on each of 2
regimens Failure to achieve a complete remission (CR) after 6 courses of 1 or 2 regimens
Relapse less than 1 year off initial therapy OR Diagnosis of intermediate- or high-grade
non-Hodgkin's lymphoma (NHL) Eligible subtypes: Diffuse poorly differentiated lymphocytic
Diffuse mixed lymphocytic-histiocytic Nodular histiocytic Diffuse histiocytic Diffuse
undifferentiated Lymphoblastic Must meet 1 of the following conditions: Disease progression
after 1 course of prior therapy Failure to achieve a PR after 2 courses of prior therapy
Failure to achieve a CR after 6 courses of prior therapy OR Diagnosis of low-grade NHL
Eligible subtypes: Diffuse well-differentiated lymphocytic Nodular poorly differentiated
lymphocytic Nodular mixed lymphocytic-histiocytic Failure on second-line therapy
administered for progressive symptomatic disease or organ compromise Measurable disease by
physical exam, external imaging or scanning studies, or tumor markers No severe symptomatic
CNS disease of any etiology History of prior CNS tumor allowed if no signs or symptoms at
study entry Active CNS lymphoma (meningeal lymphomatosis) rendered disease-free by
conventional therapies allowed Epidural metastases or discrete parenchymal brain lesions
allowed if tumors can be encompassed in standard treatment fields Bilateral marrow core
biopsy free of tumor and showing at least 30% cellularity Prior marrow involvement allowed
if marrow is histologically normal at time of storage No significant skin breakdown due to
tumor or other disease A new classification scheme for adult non-Hodgkin's lymphoma has
been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace
the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this
protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 15 to 65 Performance status: Karnofsky 70-100% OR ECOG 0-1
Life expectancy: At least 8 weeks without transplantation Hematopoietic: Granulocyte count
at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than
1.8 mg/dL SGOT and SGPT less than 2 times normal No high risk for veno-occlusive disease of
the liver Renal: No severe renal dysfunction unless due to tumor invasion Creatinine no
more than 1.5 mg/dL Creatinine at least 60 mL/min Cardiovascular: No severe cardiovascular
dysfunction unless due to tumor invasion No myocardial infarction within the past 6 months
No symptoms of major heart disease Ejection fraction at least 50% by MUGA scan Essential
hypertension controlled with medication allowed Pulmonary: No severe pulmonary dysfunction
unless due to tumor invasion DLCO at least 50% normal No symptomatic obstructive or
restrictive pulmonary disease Other: No insulin-dependent diabetes mellitus No
uncompensated major thyroid or adrenal dysfunction No active infection HTLV-III negative
(no AIDS-related complex)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy (at least 6 weeks since prior
nitrosoureas or mitomycin) Prior exposure to etoposide, cisplatin, or carmustine allowed if
cumulative dose of chloroethylnitrosourea (carmustine or lomustine) no greater than 400
mg/m2 Prior doxorubicin or daunorubicin dose of 450 mg/m2 or more allowed if LVEF at least
50% No concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids for
hypercalcemia allowed Radiotherapy: See Disease Characteristics No prior whole-pelvic
radiotherapy Other prior radiotherapy allowed Surgery: Not specified Other: No concurrent
nitroglycerin preparations for angina pectoris No concurrent antiarrhythmic drugs for major
ventricular arrhythmias